Re-forming device in particular for mixing substances in the medical field

ABSTRACT

The invention concerns a re-forming device in particular for mixing substances in the medical field, comprising a hollow needle ( 2 ) pointed at its two tips and fixed on a support ( 3 ) defining two coaxial sleeves enclosing each end of the needle and designed to receive, one ( 8 ), the plug opening ( 9 ) of a vial ( 10 ), the other ( 4 ), the hub ( 6 ) of an injection tube ( 6 ) of a flexible bag ( 7 ), so as to communicate, by perforating said plug ( 9 ) and hub ( 6 ), the vial ( 10 ) and the flexible bag ( 7 ) via said needle ( 2 ). The invention is characterised in that said sleeve ( 4 ), on the side of the flexible bag ( 7 ), is dimensioned and designed to be engaged on the hub ( 5 ) in a first stable position wherein the device ( 2 ) is secured to the bag ( 7 ) without the needle ( 2 ) being in contact with the hub ( 5 ) and said sleeve ( 4 ) is mounted sliding on the hub ( 5 ) so as to pass, through simple depression of the device ( 1 ) on the hub ( 5 ), from the first position into a second position, corresponding to the perforation of the hub ( 5 ) by the needle ( 2 ). The invention is applicable in the medical field.

[0001] The present invention relates to the mixing of one substance withanother substance, particularly in the medical field, so as for exampleto reconstitute a medication by means of a diluant.

[0002] More precisely, the invention relates to the device, commonlycalled a reconstitution device, adapted to carry out such a mixing.

[0003] Various medications that must be interjected intravenously into apatient must first be mixed with a diluant which can for example be adextrose solution, a saline solution or even water.

[0004] A good number of these medications are stored in glass vials inthe form of powder or in the liquid condition.

[0005] At the time of their administration, these medications must bemixed with a diluant contained in a flexible bag provided for thispurpose with an injection tube comprising a tip of a material such asrubber for example, adapted to be pierced by a needle, the passageformed by this latter closing itself upon retraction of the needle.

[0006] Conventionally, the communication between the vial of medicationand the flexible bag is ensured with the help of a reconstitution deviceconstituted by a hollow needle pointed at both its ends and projectinginto two open cylindrical sockets disposed head to tail and shaped toreceive, one of them, the mouth of the vial with its rubber plug forexample and, the other, the tip of the injection tubing of the flexiblebag.

[0007] At the time of use of the medication, the reconstitution deviceis separated from its sterile packaging, the needle, on the vial side ofthe device is sunk through the plug, then the other needle is alsointroduced through the tip of the flexible bag, the communicationbetween this latter and the vial being thus ensured by way of thereconstitution device.

[0008] Such a system has the drawback of requiring separate storing ofthe flexible bags, the vials and the reconstitution devices.

[0009] The object of the present invention is to simplify this systemand to render it more economical by associating the reconstitutiondevice and the flexible bag upon production of this latter bypre-positioning said device, and by packaging the device plus bagassembly in a single sterile package.

[0010] To this end, the invention has for its object a reconstitutiondevice particularly for mixing substances in the medical field, of thetype comprising a hollow needle, pointed at both its ends and fixed on asupport defining two coaxial sockets enclosing each end of the needleand adapted to receive, one of them, the plugged mouth of a vial and,the other, the tip of an injection tube of a flexible bag, such that bya perforation of said plug and tip, to place the vial and the flexiblebag into communication via said needle, characterized in that saidsocket, on the flexible bag side, is so dimensioned and arranged as toengage on the tip in a first stable position in which the device issecured to the bag without the needle being in contact with the tip andin that said socket is slidably mounted on the tip so as to pass, by asimple sinking of the device into the tip, from said first position to asecond stable position corresponding to the piercing of the tip by theneedle.

[0011] It is thus possible to store particularly in a sterile package,the flexible bag-reconsituttion device assembly which forms a unitaryassembly ready to be used because the reconstitution device is alreadyin place, without however the needle being inserted in the tip of thebag whose content can thus remain totally isolated from the outside. Asingle assembly is thus to be managed, stored and handled.

[0012] At the time of use of the bag, it suffices to remove the sterilepackaging if there is one, engage the plug of a vial in the socket ofthe device so as to pierce the plug, then to sink the reconsitutiondevice-vial assembly on the tip until this latter is pierced and itscomplete engagement in the receiving socket takes place, such that thereconstitution device will be operational.

[0013] The vial surface of the device can be conventional and comprise aconventional socket for the reception of what is also a conventionalvial.

[0014] Preferably, the reconstitution device is provided withpositioning and retaining means, at least in the first of the mentionedpositions, for the tip socket on the tip of the injection tube of theflexible bag.

[0015] The invention also has for its object the assembly constituted bya flexible bag provided with at least one injection tube with apre-positioned tip in said first retaining position in the socket inquestion of the reconstitution device.

[0016] The device of the invention thus has substantial advantages,particularly as to ease of management and use.

[0017] Other characteristics and advantages will become apparent fromthe description which follows, of an embodiment of the device of theinvention, which description is given solely by way of example and withrespect to the accompanying drawing, in which:

[0018]FIG. 1 is an axial cross-sectional view of a reconstitution deviceaccording to the invention;

[0019]FIG. 2 shows the device of FIG. 1 in place in a ready position onthe end of an injection tube of a flexible bag and,

[0020]FIG. 3 shows the device of FIG. 1 in the second or operationalposition.

[0021] The reconstitution device shown at 1 in FIG. 1 comprises a hollowneedle 2 passing through a circular support 3 prolonged toward eachpointed end of the needle, by a cylindrical socket.

[0022] One of the sockets (4) is adapted to receive (FIGS. 2 and 3) thetip 5 of an injection tube 6 of a flexible bag 7.

[0023] The other socket 8, disposed head to tail relative to the socket4, has a greater diameter to receive the mouth provided with a plug 9(FIG. 3) of a vial 10 of medication for example. The socket 8 has aninternal diameter adapted to the vial 10 and is closed during non-use bya plug B for safety. The length of the socket 8 is slightly greater thanthat of the projecting portion of the needle 2.

[0024] The socket 4 is very substantially longer than the projectingportion of the needle 2 so as to receive (FIG. 2) all of the tip 5 in aregion at a distance from the pointed end of said needle.

[0025] The internal diameter of the socket 4 corresponds to the externaldiameter of the tip 5 whose wall is of resilient material.

[0026] The tip 5 is of conventional structure of a material such aslatex permitting its piercing by the needle 2, the passage hole closingby itself after retraction of the needle, as is also true of thematerial of the plug 9.

[0027] At its inlet opening, the socket 4 is provided internally with aslight annular flange 11, discontinuous as shown, or not, provided thatat a distance from this flange 11 corresponding to the length of the tip5 are provided one or several small internal projections, for exampletwo projections 12 diametrically opposed, shaped to the end of twotongues 13 cut out from the wall of the socket 4.

[0028] The device 1 is of one-piece construction and made for example bymolding a suitable plastic material.

[0029]FIG. 2 shows the device 1 pre-positioned on the injection tube 6,in the ready position. The device 1 is located in its first stableposition, the tip 5 having been engaged in the socket 4 forcefully topop over, thanks to the resilience of the tip, the inlet flange 11, thetip 5 being introduced completely and being stopped in this firstposition by the two projecting abutments 12.

[0030] In this stable ready position, the point of the needle 2 is heldat a distance from the tip 5 and the device 1 forms a body with theflexible bag 7. The assembly can thus be manipulated, packaged in asterile flexible packaging, stored and managed as a single item.

[0031] During use of the bag 7, which is to say when it is desired tomix the content of the vial 10 with a dilution liquid, for examplecontained in the bag, the device 1 is first placed on the tubing 6 inthe position of FIG. 2 (ready position). Then the vial 10 is introducedby its plug 9 into the socket 8 such that the plug is pierced. Finally,the assembly of device 1-vial 10 is pressed in the direction of the bag7 so as to pierce the tip 5 by the needle.

[0032] At the beginning of this movement, it is necessary to overcomethe slight resilient resistance of the projections 12 which retract tolet the tip pass, then all of the tip 5 is pierced by the needle 2, andfinally the tip comes into abutment in the second stable position of thedevice 1 against a cone 14 provided in the bottom of the socket 4.

[0033] The two receptacles 7 and 10 are thus in communication via theneedle 2 and the tube 6.

[0034] It is of course possible to provide this communication by firstengaging the plug 9 of the vial 10 into the socket 8 to pierce the plug,then by engaging the assembly of the device 1-vial 10 on the tip 5 so asfinally to piece the tip 5 and to bring the assembly into the positionof FIG. 3.

[0035] The device of the invention has the advantage of permittingwithdrawing the assembly of the device 1-vial 10 from the tip 5 afterthe reconstitution operation. Thus, the operator will have a bag 7 withwhich he can, via the tube 6, carry out an additional injection ifnecessary. According to another advantage, the separation between thebag 7 and the assembly 1-10 is desirable for optimum treatment ofhospital waste.

[0036] Finally, the invention is clearly not limited to the embodimentshown and described above, but on the contrary covers all modifications,particularly as to the means 11, 12 for positioning-blocking the tip 5in its first position. It is to be noted that the socket 8 could ifdesired be provided internally in the manner known with one or severalprojections, three for example, such as shown at 15 in the figures, soas resiliently to retain in the correct sunken position the plug 9 ofthe vial, and externally also in known manner, with one or severalprojections, three for example, such as shown at 16 to retain the plugB.

1. Reconstitution device particularly for mixing substances in the medical field, of the type comprising a hollow needle (2), pointed at both its ends and fixed on a support (3) defining two coaxial sockets enclosing each end of the needle and adapted to receive, one of them (8), the plugged mouth (9) of a vial (10) and the other (4), the tip (5) of an injection tube (6) of a flexible bag (7), such that, by perforation of said plug (9) and tip (5), to place in communication the vial (10) and the flexible bag (7) via said needle (2), characterized in that said socket (4), on the flexible bag side (7), is dimensioned at a range to engage on the tip (5) in a first stable position in which the device (1) is secured to the bag (7) without the needle (2) being in contact with the tip (5) and in that said socket (4) is slidably mounted on the tip (5) so as to pass, by simple sinking of the device (1) against the tip (5), from said first position to a second stable position corresponding to the piercing of the tip (5) by the needle (2).
 2. Device according to claim 1, characterized in that it comprises means (11, 12) for positioning and retaining said socket (4) on the tip (5) in at least the first of said positions.
 3. Device according to claim 2, characterized in that said means comprise a continuous or discontinuous flange (11) projecting inwardly adjacent the inlet opening of the socket (4).
 4. Device according to claim 2 or 3, characterized in that said means comprise one or several projections (12) resiliently retractable, arranged within the socket (4) and located at a distance from the inlet opening of the socket (4) corresponding to the length of the tip (5).
 5. Assembly constituted by a flexible bag (7) provided with at least one injection tube (6) with a tip (5) pre-positioned between said means (11, 12) for positioning and retention of the socket (4) of the device, according to one of claims 2 to
 4. 